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Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
BNCT(boron neutron capture therapy)
XRT(X-ray radiation treatment)
TMZ(temozolomide)
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme

    • Newly diagnosed disease

  • Tumor located at a supratentorial hemisphere

    • Deepest part of tumor < 6 cm from the scalp
    • Bottom of the tumor > 6 cm from the scalp allowed provided air instillation into tumor-removed cavity is possible
  • No cerebrospinal fluid dissemination

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy > 3 months
  • Leukocyte count ≥ 3,000/μL
  • Platelet count ≥ 10.0 × 10^4/μL
  • Hemoglobin ≥ 8.0 g/dL
  • Serum creatinine ≤ 1.5 mg/dL
  • ALT and AST ≤ 100 IU/L
  • No phenylketonuria
  • Not pregnant or nursing
  • No NYHA class III-IV heart failure
  • No patient whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy

Sites / Locations

  • Osaka Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment

Outcomes

Primary Outcome Measures

Overall survival (OS)

Secondary Outcome Measures

Tumor response（RECIST）
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Adverse event

Full Information

First Posted
September 10, 2009
Last Updated
April 24, 2018
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Department of Nuerosurgery, Osaka Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT00974987
Brief Title
Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title
A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 1, 2009 (Actual)
Primary Completion Date
February 29, 2016 (Actual)
Study Completion Date
February 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Department of Nuerosurgery, Osaka Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Boron neutron capture therapy and radiation therapy use high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving boron neutron capture therapy followed by radiation therapy and temozolomide may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving boron neutron capture therapy together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.
Detailed Description
OBJECTIVES: Evaluate the overall survival of patients with newly diagnosed glioblastoma multiforme treated with boron neutron capture therapy, radiotherapy, and concurrent and adjuvant temozolomide. Evaluate tumor response in patients treated with this regimen. Evaluate the adverse effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo boron neutron capture therapy followed by radiotherapy and concurrent and adjuvant oral temozolomide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
BNCT(boron neutron capture therapy), XRT(X-ray radiation treatment) and TMZ(temozolomide) treatment
Intervention Type
Radiation
Intervention Name(s)
BNCT(boron neutron capture therapy)
Intervention Description
BSH(sodium borocaptate) 100mg/kg iv for one hour starting 13 hours before irradiation, and BPA(p-boronophenylalanine) 500/mg/kg iv at a speed of 200mg/kg/hr for 2 hours starting 2 hours before irradiation. During irradiation, BPA iv continues at a speed of 100mg/kg/hr.
Intervention Type
Radiation
Intervention Name(s)
XRT(X-ray radiation treatment)
Intervention Description
After BNCT, 2Gy irradiation every day for 12 days.
Intervention Type
Drug
Intervention Name(s)
TMZ(temozolomide)
Intervention Description
75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Time to death from BSH injection（up to 6 years）
Secondary Outcome Measure Information:
Title
Tumor response（RECIST）
Time Frame
From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Title
Objective Response Rate (ORR)
Time Frame
From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Title
Disease Control Rate (DCR)
Time Frame
From BSH injection to the end of treatment, whichever came first, assessed up to 96 weeks
Title
Adverse event
Time Frame
Time to final follow-up survey from the date of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme Newly diagnosed disease Tumor located at a supratentorial hemisphere Deepest part of tumor < 6 cm from the scalp Bottom of the tumor > 6 cm from the scalp allowed provided air instillation into tumor-removed cavity is possible No cerebrospinal fluid dissemination PATIENT CHARACTERISTICS: Karnofsky performance status 70-100% Life expectancy > 3 months Leukocyte count ≥ 3,000/μL Platelet count ≥ 10.0 × 10^4/μL Hemoglobin ≥ 8.0 g/dL Serum creatinine ≤ 1.5 mg/dL ALT and AST ≤ 100 IU/L No phenylketonuria Not pregnant or nursing No NYHA class III-IV heart failure No patient whose participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin-Ichi Miyatake, MD, PhD
Organizational Affiliation
Osaka Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka Medical College
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21459588
Citation
Kawabata S, Miyatake S, Hiramatsu R, Hirota Y, Miyata S, Takekita Y, Kuroiwa T, Kirihata M, Sakurai Y, Maruhashi A, Ono K. Phase II clinical study of boron neutron capture therapy combined with X-ray radiotherapy/temozolomide in patients with newly diagnosed glioblastoma multiforme--study design and current status report. Appl Radiat Isot. 2011 Dec;69(12):1796-9. doi: 10.1016/j.apradiso.2011.03.014. Epub 2011 Mar 21.
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Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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